Catheter anchoring device and method

ABSTRACT

Methods and apparatus for anchoring a catheter to a patient&#39;s skin using a catheter anchoring device are described. The catheter anchoring device includes one or more pairs of sharps with a sharpened end configured to pierce the surface of the skin. A locking mechanism for the sharps is used as a failsafe mechanism. The catheter anchoring device further includes a catheter clamp for securing a catheter to the catheter anchoring device. Releasing the clamp allows an operator to reposition and secure the catheter at the new position without moving the catheter anchoring device.

RELATED APPLICATIONS

This Application claims priority under 35 U.S.C. § 119(e) to U.S.Provisional Application Ser. No. 61/841,048, entitled “CATHETERANCHORING DEVICE AND METHOD” filed on Jun. 28, 2013, which is hereinincorporated by reference in its entirety.

BACKGROUND Technical Field

The present disclosure relates to medical devices and more particularlyto the process of anchoring medical catheters to the skin of humanpatients to prevent movement of a catheter after insertion into thebody. The catheter anchors described may also be used in a similarfashion for veterinary use.

Discussion of the Related Art

One of the most common medical procedures performed each year is theinsertion of catheters into the body for the purpose of deliveringfluids to or extracting fluids from a specific part of the body and/orextracting air from a specific part of the body. Examples of cathetersinclude but are not limited to central venous catheters (CVC) whichdeliver fluids intravenously to a vein typically in the chest, neck, orgroin; peripherally inserted central catheters (PICC lines) whichdeliver fluids intravenously typically in the arms; chest tubes whichextract fluids and/or air from the chest cavity; gastrostomy tubes(G-tubes) which deliver fluids to the stomach; jejunostomy tubes(J-tubes) which deliver fluids to the jejunum; and Hickman catheterswhich are used in chemotherapy and hemodialysis. An additional type ofcatheter uses a wire to deliver current to a specific part of the body.A trans-venous pacemaker wire that is placed temporarily into the heartis an example of a wire-based catheter that delivers current to theheart instead of fluids. Each of these and other catheters and linesthat enter into the body should be stably anchored to the patient's skinso that their precise placement into the vein, heart, chest cavity,stomach, jejunum, etc. is not disturbed by movement of the patient sothat the catheter or line can achieve its intended delivery orextraction purpose. Furthermore, it is important that the catheter orline remain in its inserted location to prevent damage to the patientincluding tearing of the skin, dislodging of the catheter, rupturing ofthe vein, accidental removal, or other consequential damage from theunintended movement of the catheter. For this purpose, typically acatheter anchor is attached to the patient's skin near the catheter orline insertion site, and the catheter or line is mechanically tetheredto this anchor to prevent the catheter or line from being moved ordisturbed.

A common methodology for anchoring the catheter or line to the patient'sskin is the use of a catheter anchor that can be sutured to thepatient's skin. These catheter anchors come in various sizes andconfigurations to accommodate catheters of different diameters and someare affixed directly to the catheters themselves, but they typicallywork in the same fashion. They are typically applied by a physician dueto the skill needed to suture them to the patient. In typical use aphysician will insert a catheter into a patient to a particular depth orposition. Next the physician will place a form-fitting non-slip pliablesleeve typically made of silicone around the catheter near the insertionpoint into the body. The physician then places, for example, a hardplastic cap that is keyed to the silicone sleeve over the sleeve. Thiscap typically has two holes that are parallel to the patient's skin whenin position. Once the cap is in position, the physician will suture thecap using a straight or curved exposed needle and non-dissolvable suturethread to the patient's skin using the two holes in the cap. Thephysician should be careful not to penetrate the skin too deeply so asnot cause excessive bleeding, nerve damage, or other physical damage tothe patient but should also penetrate deeply enough to securely anchorthe catheter. The suturing process involves inserting the needle throughthe skin on each side of the cap, drawing the suture threads through theskin, and then tying the loops of thread to each side of the cathetervia their respective holes. Due to the dangers associated with the openneedle, it is critical that the patient remain still during theinsertion procedure. The process of attaching the catheter to thepatient's skin in ideal circumstances takes approximately 3 minutesafter the catheter has been properly positioned. If a patient is notstill during the procedure, then the suturing process can takeconsiderably longer. After the physician completes the suturing process,medical adhesive tape is then applied over the sutured catheter anchorto further secure the catheter anchor and to cover the puncture woundsmade by the needle to reduce the risk of contamination and subsequentinfection. Once the catheter anchor has been sutured to the patient, itis difficult to move or adjust the catheter. The exact position of thecatheter is almost always verified by x-ray. If the physician needs toreposition the catheter at all (which happens frequently), then thephysician has to cut and remove the sutures, remove the catheter anchorcap, reposition the catheter, and repeat the entire suturing process asdescribed above. This results in additional wounds in the patient's skinand tissue, consequently multiplying the risk of infection or theaforementioned other risks to the patient. A catheter anchor asdescribed can usually remain in place on a patient's skin for a limitedtime (typically up to a week). During that time, the wound area createdby the needle punctures and the catheter insertion site must be cleanedas frequently as necessary with a disinfecting cleaning solution such asBetadine to reduce the risk of infection to the patient. Millions ofcatheters of all different sizes and types are inserted into patients inthe US every year, most requiring at least one catheter anchor perinsertion.

There are several safety risks to both the physician and the patientinvolved with the insertion of a typical sutured catheter anchor. Onerisk is a needlestick injury to the physician. If the physician who iswearing protective surgical gloves comes in contact with the patient'sblood via puncturing of the physician's skin by the infected needle, thephysician may contract any number of diseases born by the patient. Insome cases this may lead to a chronic or life-threatening diseaseincluding HIV infection or Hepatitis which are passed from one human toanother by blood to blood contact. The risks associated with aneedlestick injury can be very serious. In many hospitals, it is arequirement that a physician undergo expensive testing for possibleinfection whenever there is a contaminated or suspected contaminatedneedlestick injury. The risk of a needlestick injury is significant whenusing an unprotected needle even when the patient is completely still.If a patient is agitated or unstable, the risk of a needlestick injuryis greatly increased due to the unpredictable motion of the patient. Apatient can also be subject to a needlestick injury if the physicianunwittingly punctures his or her skin during the suturing process andthen contaminates the patient with the infected needle.

Needlestick injuries have become a very serious health risk for medicalprofessionals. According to the CDC, more than 800,000 needlestickinjuries take place in the US alone each year, and this number does notreflect the numerous needlestick injuries that go unreported. Of these800,000 needlestick injuries, more than 380,000 happen to hospital-basedmedical personnel, resulting in more than 1,000 cases of seriousinfections to physicians or other medical practitioners every year.

Therefore, any measure that can reduce needlestick injuries is bothpotentially lifesaving and highly cost effective. Due to the seriousrisks associated with needlestick injuries including blood-borneinfections of fatal and incurable diseases, Congress enacted the USNeedlestick Safety and Prevention Act which mandates the use of saferalternative methodologies to conventional needles whenever it ispossible to do so. Insurance companies also follow the same safetyguidelines.

Another significant risk to the patient during and after the insertionof a sutured catheter anchor is infection. While the physician takesgreat care not to contaminate the needle or the wound sites made by theneedle, infections can and do enter the patient's bloodstream via thewound sites. This can lead to significant complications for the patientdepending on the type of infection and the patient's health, and in somecases may become life-threatening or lead to death. Reducing infectionis important during the insertion of any catheter and catheter anchor.Any time a needle enters, exits, and then re-enters the skin, the riskof contamination increases, and consequently the risk of infection tothe patient increases. Additionally, each time a needle enters the skin,a new wound site is generated; and with each additional wound site, therisk of infection increases. Therefore, the drawing of the exposedneedle or suture thread through the patient's skin and out againincreases the risk of infection to the patient by both increasing thenumber of wound sites and by potentially drawing contaminants into thepatient's skin which can come in contact with the patient's bloodstream.This can even occur when the suturing process is conducted in a cleanhospital environment.

The risk of damage done by the insertion of the needle is yet anothersafety issue. Even a skilled physician can damage the patient's skin,underlying tissue, nerves, blood vessels, or worse if the patient movesunexpectedly during the time that the needle has penetrated thepatient's body. The needle insertion typically is only done between adepth of 3 and 5 mm below the surface of the skin (depending on theinsertion location on the body) to reduce bleeding and nerve pain ordamage which takes great care and skill by the physician. Given thetypical time that is needed to suture a catheter anchor and the numeroustypes of conditions under which a catheter anchor might be applied, itis not uncommon for the needle to cause an injury to the patient whichcould be minor or significant. Older patients who have very thin skin(i.e. shallow epidermis and dermis layers) and minimal fat tissue in thesubcutaneous layer of the skin (hypodermis) are particularly at risk forthis type of injury especially for catheter insertions in the neck.

The depth of penetration into the skin is an important factor forpatient comfort and for mitigating consequential damage such asexcessive bleeding and tearing of the skin. The top two layers of theskin (the epidermis and dermis layers) are typically 2-4 mm in depthdepending on the location on the body. Since the majority of the nerveendings lie at the junction of the epidermis and dermis layers, it isdesirable to penetrate through the dermis layer and into thesubcutaneous layer of the skin to avoid excessive discomfort and toreduce the risk of tearing the skin while the catheter anchor is inplace. Penetrating the skin deep into the subcutaneous layer runs therisk of reaching the underlying muscle layer or bone depending on theinsertion location, and excessive bleeding may occur due to the presenceof larger blood vessels, veins, and arteries. The depth of the skin willalso vary based on the age of the patient (due to decreased amounts offat cells), the general health of the patient, and the body mass indexof the patient. The skin in the neck, for example, is most frequentlythinner than the skin in the chest. Therefore, it would be desirable tohave a reliable penetration depth of the sharps to reduce theaforementioned negative consequences of a needle insertion, whilemaximizing the holding strength of the catheter anchor.

There have been numerous attempts to create alternative catheter anchorsto the common sutured catheter anchor. One type uses an adhesive backedbase which adheres to the patient's skin. While no needles or sharps areemployed in this methodology, the drawbacks to this type of catheteranchor are significant. First, the adhesive can cause significantirritation to the skin of some patients. Second, removal of the adheredcatheter anchor can cause significant damage to the patient's skinincluding tearing, and the removal process can be slow and painstaking,sometimes requiring the use of harsh chemicals. Third, adhesive-typecatheter anchors are difficult to apply to wet, sweaty, or compromisedskin. And the nature of the adhesive makes it not strong enough to holdmost sizes of catheters on the patient's skin, making it suitable onlyfor normally taped applications such as PICC lines. Some manufacturersof these adhesive-type catheter anchors acknowledge their weaknesses intheir own instruction literature and recommend them only for use as asubstitute for taped applications, making them unsuitable for catheterapplications that normally require sutured catheter anchors.

Another type of catheter anchor employs a single-sided sharp or set ofsharps that penetrate the skin and then re-emerge through the skin tolock into a plastic base which contains the anchoring mechanism for thecatheter. U.S. Pat. No. 6,572,587 to Lerman et al. teaches one suchmethod. U.S. Pat. No. 7,914,498 to Daniels, Jr. et al teaches anothervery similar method. In these examples and others, the exposed tip ofthe sharp which exits the skin to engage with the housing duringinsertion into the patient's skin becomes a potential risk for infectionto the patient. While the tip of the sharp is exposed to the air (i.e.during the entire time the catheter anchor is attached to the patient)it may be exposed to contaminants. In order to remove the catheteranchor from the patient, the exposed portion of the sharp is drawn backunderneath the skin and through the underlying tissue, potentiallyexposing the contaminated tip to the patient's bloodstream andincreasing the risk of infection over the common suturing methodology.

One significant reason that sharp or needle-based catheter anchors havenot been successful in supplanting the sutured catheter anchor is thatnone have solved the issue of eliminating or significantly reducingneedlestick injuries. These types of catheter anchors can causeneedlestick injuries either before, during, or after insertion, and thislack of full protection against needlestick injuries may be responsiblefor the lack of adoption of these methodologies. Lerman et al. describesthe shortcomings of numerous prior art catheter anchors that fail toprotect the operators and patients from needlestick injuries. Lerman etal. also claims to have reduced the risk of needlestick injury with itsinvention, but Lerman lacks any failsafe mechanism to prevent aneedlestick injury during insertion or removal. Furthermore, once thecontaminated device has been removed from a patient, there is nothing toprevent the operator or any other person who may come in contact withthe device from deploying its sharps and potentially incurring aneedlestick injury. In addition, there is no mechanism that prevents thereuse of the device which could cause grave injury after contamination.In fact, Lerman et al. even teaches that its device may be re-insertedinto a patient's skin after removal as a methodology for anchoring if acatheter has to be repositioned. Daniels, Jr. et al. does not evenmention the risks of needlestick injuries nor teaches any methodology toreduce the risk of needlestick injuries.

SUMMARY

In nearly all medical procedures improvements in speed are beneficial toimproving the efficiency of the delivery of care for medicalpractitioners—especially physicians. Moreover, improvements in speed ofa medical procedure can be life-saving in trauma and triage situationsin the hospital, in the field, or in battlefield situations. Embodimentsof the present disclosure substantially improve the speed andreliability of the insertion of a catheter anchoring device.

Embodiments can prevent the sharps from being deployed accidentallyduring the insertion process. Embodiments can also lock the points ofthe sharps within the device securely before the device is removed fromthe surface of the patient's skin thereby reducing any chance of aneedlestick injury to the operator and/or any subsequent personnel whocome in contact with it.

An important factor for patient comfort after insertion is the relativepositions of the pointed ends of the sharps. If the pointed ends of thesharps remain free after insertion under the skin, then the patient mayexperience discomfort during movement akin to having a splinter imbeddedin the skin known as the “splinter effect.” To eliminate the splintereffect, an embodiment has the point of each pair of opposing sharps nestinto each other. This nesting prevents the sharp point of each needlefrom irritating the patient's skin while inserted. This essentiallyclosed arc has the further benefit of creating a stronger anchor thaneven a surgical staple where the points nearly meet but do not overlap.

With a patient completely motionless, it typically takes a skilledphysician approximately three minutes to completely attach a suturedcatheter anchor to the patient once a catheter has been inserted intothe body. If the patient is agitated or less than ideal conditions arepresent, this process can take considerably longer. The catheter anchorshould also be precisely placed before suturing, as it is difficult toreposition the catheter after the catheter anchor is sutured into place.When using a sutured catheter anchor the greatest risk from theprocedure, particularly one in which the patient is not motionless, isan inadvertent needlestick injury. Any attempt to speed up the processof inserting the catheter anchor using an unprotected needle (e.g. in atrauma situation where time is of the essence) greatly increases thechances of a needlestick injury.

The embodiments overcome several shortcomings of the sutured catheter.First, the insertion process of the embodiments nominally takes onlyabout 10-15 seconds in total to fasten the catheter anchor to thepatient's skin and to secure the catheter to the catheter anchor.Second, once the catheter anchor is secured, the catheter can berepositioned as often as needed by releasing the catheter clampingmechanism, repositioning the catheter to its new desired position, andthen relocking the catheter clamping mechanism which also takes just amatter of seconds to accomplish. Third, the sharps are not exposed tothe physician or other medical personnel at any time. The sharps canonly be deployed when the catheter anchor is lying on the surface of thepatient's skin and the catheter has already been inserted into thepatient (due to the catheter anchor's interlock mechanism), preventingthe sharps from penetrating anything but the patient's skin. During thetime that the catheter anchor is attached to the patient, the sharps arenested safely in pairs below the patient's skin under the catheteranchor. During the removal process, the sharps are retractedautomatically via a spring-loaded mechanism, and the tips of the sharpsbecome permanently and completely encased within the catheter anchorhousing before the catheter anchor can be lifted from the patient'sskin. Therefore, there is no time when the ends of the sharps areexposed to the physician or other medical personnel, eliminating anychance of a needlestick injury.

This substantial increase in speed of insertion yields numerousbenefits. In trauma and triage situations, the time savings can becritical to the patient's survival. In nearly all situations, thephysician will save valuable time to perform other procedures andduties, increasing his/her efficiency. If a patient is not completelymotionless, the substantial increase in speed enables the physician toinsert the catheter anchor in a matter of seconds—dramatically reducingthe risk of injury to the patient or physician over conventionalsuturing. In any instance where a catheter needs to be repositioned oradjusted after insertion (which happens frequently), the time savings isquite substantial as the sutured catheter anchor would have to beremoved and a new one sutured in its place in the new position, wastinga significant amount of time. Embodiments of the present disclosure,which do not have to be removed to allow for the re-positioning of thecatheter, obviate these risks.

Embodiments also provide for easy and reliable insertion into a patient.As previously described, the depth of penetration into the skin is veryimportant to reduce the risk of injury and/or discomfort to the patient.Suturing with a conventional straight or curved needle within theconfines of that very shallow and specific depth takes great skill,patience, and dexterity; and this procedure is typically only performedby physicians. Embodiments greatly simplify the insertion process andmake the insertion more reliable. The depth of penetration of the curvedsharps is preset to fall within the narrow range of the dermis andsubcutaneous layer of the skin depending on the location of insertion onthe body (i.e. approximately 4-5 mm at full depth) so that thepractitioner does not have to worry about penetrating the skin tooshallowly or too deeply, consequently eliminating the risks associatedwith penetration outside of the desired safe range. The operator neednot have the skill or dexterity that a physician who sutures would have,for the difficulty and precision of an unprotected needle insertion iseliminated. This makes embodiments suitable for anchoring all types ofcatheters including PICC lines. In addition, embodiments can be appliedquickly when time is of the essence such as in trauma situations. Thereliability of operation of the embodiments extends to patients withlacerated or damaged skin, patients who are agitated, patients who havewet or sweaty skin, and patients with an abundance of hair on theirskin. Thus, regardless of the location of insertion, the condition ofthe patient's skin, and the motion of the patient, the operator canquickly, easily, and reliably insert the catheter anchor securely andsafely into the patient and secure the catheter in place. Since theposition of the catheter is fully adjustable after the catheter anchorhas been inserted, the precision of placement associated with aconventional sutured catheter is obviated.

Another advantage of the embodiments is that they provide a completelyself-contained device which does not require any additional insertion orextraction instruments or tools. The self-contained catheter anchorreduces the chances of contamination and consequent infection since thesharps are only exposed as they are being deployed into the patient'sskin. Unlike a conventional sutured catheter anchor or a stapledcatheter anchor (such as taught by U.S. Pat. No. 5,730,758 to Allgeyer)there are no exposed sharps or needles and no tools which may be droppedor contaminated during the insertion or extraction process. Furthermore,any tools or additional materials (such as the needle or suture) neededto insert the catheter anchor could be lost or misplaced during theprocedure, further slowing the process of insertion or extraction.Proprietary tools or instruments are also likely to increase the cost ofthe procedure.

The embodiments add other benefits to the process of anchoring cathetersto patients. The embodiments provide a device for attaching an apparatusto a body which:

-   -   (a) Can be securely attached to the body without the risk of a        needlestick injury to the physician or patient;    -   (b) Can be safely detached from the patient's body without the        risk of a needlestick injury to the physician or patient;    -   (c) Is completely self-contained and does not require additional        implements for insertion or removal;    -   (d) Reduces the risk of infection;    -   (e) Can be securely attached very quickly and safely on all        types of skin surfaces regardless of the physical motion of the        patient;    -   (f) Can be removed quickly and safely on all types of skin        surfaces without harming the patient's skin;    -   (g) Can quickly and reliably secure a catheter in place;    -   (h) Has the ability to allow the catheter to be released for        readjustment or movement and then re-secured without detaching        the device from the patient's skin as many times as needed;    -   (i) Has a predictable and reliable insertion depth into the        patient's skin which minimizes discomfort to the patient during        the insertion process and during the entire duration of its        attachment to the patient;    -   (j) Is small and compact so it will be less obtrusive to the        patient, will not interfere with care of the patient, and will        not inhibit the movement or mobility of the patient;    -   (k) Can be operated easily and reliably by an operator with        straightforward training;    -   (l) Contains a mechanical failsafe interlock mechanism which        prevents the sharps from deploying until the device is properly        placed on the patient's skin and the catheter is in place;    -   (m) Contains a mechanical failsafe interlock mechanism that        automatically secures the sharps safely within the housing        permanently upon actuating the removal mechanism and that        prevents any reuse or accidental injury from the device;    -   (n) Can be deployed by the operator with a single hand (either        right or left);    -   (o) Can be utilized for a wide range of catheters of various        diameters and types; and    -   (p) Can be produced reliably and inexpensively so as to make it        disposable.

Embodiments work in conjunction with many prior art catheters of anysize or type. A catheter is first inserted into its desired area of thebody of a patient by the appropriate means. Once the catheter is inplace, the operator places the apparatus over the catheter on thesurface of the skin of the patient in the desired insertion location.Using a squeezing motion of the operator's thumb and forefinger, theoperator depresses the buttons on either end of the device which in turnprecisely deploy two sets of diametrically opposed sharps into thepatient's skin at a controlled depth, securely affixing the device tothe patient's body. The catheter is then locked into place on the deviceby deploying the catheter locking mechanism. At any time, the operatormay reposition the catheter by releasing the catheter locking mechanism,repositioning the catheter, and re-engaging the catheter lockingmechanism. The apparatus does not have to be removed from the patient'sskin to permit repositioning or readjustment of the catheter.

The apparatus can be easily and quickly removed from a patient's skinwhen the operator desires to do so. After the operator releases twosafety mechanisms (which prevent accidental deployment), thediametrically opposed sharps instantly, automatically, and safelyretract into the housing of the device, and the pointed ends of thesharps are permanently and safely contained within the housing so thatno one can come in contact with them. The removed device can be safelydisposed of with or without the catheter attached.

Embodiments contain multiple failsafe mechanisms to virtually eliminatethe risk of needlestick injuries before the device is attached to thepatient's skin, during the insertion process, during the entire time itis attached to the patient's skin, during removal from the patient'sskin, and after the device has been removed from the patient's skin.Consequently, neither the operator nor anyone else is at risk for aneedlestick injury at any time through the use of the device.

Embodiments vastly improve on the speed and safety with which a catheteranchor can be attached to a patient's skin over suturing methodology.Embodiments also significantly improve the speed and safety with which acatheter may be re-secured to the patient's skin after the catheter hasbeen repositioned over the suturing methodology. Furthermore, theembodiments are easier and more reliable to operate than a conventionalsutured catheter anchor, and embodiments reduce the risk of infectionover a conventional sutured catheter.

Other objects and advantages of the embodiments will become apparentfrom the following description of the embodiments in conjunction withthe accompanying drawings. Reference numbers identifying the same partsare used throughout the drawings.

According to one embodiment described herein, an anchor device isprovided. The anchor device comprises a housing having a bottom surfaceand at least one pair of sharps within the housing. Each sharp in the atleast one pair of sharps has an end configured to pierce a skin surface.The anchor device further comprises a locking mechanism configured tomaintain the end of each sharp within the housing when the lockingmechanism is engaged and to enable each sharp to protrude from thebottom surface and to pierce a skin surface when the locking mechanismis disengaged.

In some embodiments, the locking mechanism is disengaged by contactingthe bottom surface to the skin surface. In some embodiments, the lockingmechanism is disengaged by a catheter.

In some embodiments, the anchor device further comprises at least onebutton configured to be pressed by an operator to move the at least onepair of sharps when the locking mechanism is disengaged. In someembodiments, the at least one button moves parallel to the bottomsurface of the housing.

In some embodiments, the ends of each pair of sharps contact each otherunderneath the skin surface. In some embodiments, the ends of each pairof sharps are configured to be nested. In some embodiments, the ends ofeach pair of sharps touch at a depth from the skin surface. In someembodiments, the depth corresponds to a dermis layer. In someembodiments, the depth corresponds to a subcutaneous layer. In someembodiments, the depth corresponds to the range of approximately 4millimeters to approximately 5 millimeters.

In some embodiments, the anchor device further comprises a cavityconfigured to position a catheter and a catheter locking mechanismconfigured to secure the catheter within the cavity when the catheterlocking mechanism is engaged and to allow the catheter to berepositioned when the catheter locking mechanism is disengaged. In someembodiments, the catheter locking mechanism is engaged after the end ofeach sharp pierces the skin surface. In some embodiments, the catheterlocking mechanism includes securing the catheter between an innersurface of the cavity and a catheter clamp. In some embodiments, thecavity is scaled to fit a dimension of the catheter.

In some embodiments, the anchor device further comprises at least onerelease mechanism configured to retract the end of each sharp into thehousing. In some embodiments, the end of each sharp is permanentlycontained within the housing when the at least one release mechanism isengaged. In some embodiments, the at least one release mechanismincludes a release bar having a first position and a second position,when the release bar is positioned from the first position to the secondposition the end of each sharp retracts into the housing. In someembodiments, the release bar permanently resides in the second positionafter being positioned from the first position to the second position.In some embodiments, the at least one pair of sharps retractsimultaneously into the housing.

In some embodiments, the at least one pair of sharps have a radialconfiguration. In some embodiments, the at least one pair of sharps havea linear configuration. In some embodiments, the at least one pair ofsharps have a helical configuration.

In some embodiments, the bottom surface includes a membrane and the endof each sharp is configured to pierce the membrane. In some embodiments,the membrane is silicone.

In some embodiments, the sharps are stainless steel. In someembodiments, the sharps are coated with a layer of nickel.

According to another embodiment described herein, the anchor devicecomprises a housing having a bottom surface, a cavity in the bottomsurface, a locking pin configured to displace away from the bottomsurface further into the housing in response to an object being disposedin the cavity when the bottom surface contacts a skin surface, and atleast one pair of sharps within the housing. Each sharp in the at leastone pair of sharps has an end configured to pierce the skin surface.

A further embodiment described herein is directed to an anchoringmethod. The method comprises placing an anchoring device having a bottomsurface on a skin surface where the bottom surface contacts the skinsurface, releasing a locking mechanism of the anchoring device,extending at least one pair of sharps from the bottom surface of theanchoring device, and piercing the skin surface with the at least onepair of sharps when the locking mechanism is released, each sharp in theat least one pair of sharps having an end configured to pierce the skinsurface.

In some embodiments, the method further comprises moving the at leastone pair of sharps to have each pair of sharps meet at a depth below theskin surface. In some embodiments, the locking mechanism is released bydisplacing a locking pin with a catheter.

In some embodiments, the method further comprises pressing at least onebutton on the anchoring device when the locking mechanism is released toengage the end of each sharp to pierce the skin surface.

In some embodiments, the method further comprises pressing at least onebutton on the anchoring device to release the locking mechanism bygathering skin in a cavity in the bottom surface of the anchoring deviceand displacing a locking pin by the gathered skin.

In some embodiments, the method further comprises positioning a catheterin a cavity in the anchoring device and engaging a catheter lockingmechanism to secure the catheter to the catheter anchoring device. Insome embodiments, the method further comprises releasing the catheterlocking mechanism to unlock the catheter's position. In someembodiments, the method further comprises repositioning the catheter toa new position and re-engaging the catheter locking mechanism to securethe catheter at the new position.

In some embodiments, the method further comprises retracting the end ofeach sharp into the anchoring device. In some embodiments, theretracting permanently maintains the end of each sharp in the anchoringdevice.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a catheter anchoring device in theundeployed position according to one embodiment;

FIG. 2 is a cross-sectional side view of the catheter anchoring deviceof FIG. 1 in the undeployed position;

FIG. 3 is a longitudinal cross-sectional bottom view of the catheteranchoring device of FIG. 1 in the undeployed position;

FIG. 4 is another perspective view of the catheter anchoring device ofFIG. 1 in the undeployed position;

FIG. 5 is an exploded view of the catheter anchoring device of FIG. 1;

FIG. 6 is a side view of the catheter anchoring device of FIG. 1 on thesurface of a patient's skin with a catheter in the catheter channelprior to deployment;

FIG. 7 is a side view of the catheter anchoring device of FIG. 1 in thedeployed position with the catheter unlocked and a cross-sectional viewof the layers of the patient's skin;

FIG. 8 is an end view of the catheter anchoring device of FIG.1 in thedeployed position;

FIG. 9 is a longitudinal cross-sectional side view of the catheteranchoring device of FIG. 1 in the deployed position showing the latchingmechanism;

FIG. 10 is a side view of the catheter anchoring device of FIG. 1 in thedeployed position with the catheter locking mechanism deployed;

FIG. 11 is a longitudinal cross-sectional side view of the catheteranchoring device of FIG. 1 in the released position;

FIG. 12 is a perspective view of the reverse side of the catheteranchoring device of FIG. 1 in the released position;

FIG. 12A is a perspective view of the catheter anchoring device of FIG.1 with the catheter mechanism deployed;

FIG. 13-20 illustrate another embodiment of a catheter anchoring device.

DETAILED DESCRIPTION

FIG. 1 is a perspective view of a catheter anchoring device in theundeployed position according to one embodiment. The pointed ends ofeach pair of parallel radial sharps 4 are fully enclosed within housing100 of the catheter anchoring device as shown in the cross-sectionalside view of the catheter anchoring device in FIG. 2. Each pair of twoparallel radial sharps 4 are joined by a common crossbar 4 a which isanchored to a pivoting wing 9 via a tang 9 a integrated into pivotingwing 9. In one embodiment of the catheter anchoring device each pair ofradial sharps 4 and their respective crossbar 4 a are formed from acontinuous piece of wire stock. Alternatively, each individual radialsharp 4 can be joined by a separate crossbar member. The pointed ends ofeach radial sharp 4 are sharpened in opposite directions to each othershown in FIG. 2 and are sharpened to easily penetrate a patient's skinwith light pressure. Two buttons 6 are diametrically opposed to eachother on opposite ends of the catheter anchoring device and linkedthrough a pair of parallel racks 12 and a pinion gear 7 a shown as item7 in FIG. 3, and both racks 12 are linked together through the commonrotation of pinion gear 7 a. Pinion gear 7 a is held in place by androtates about a keyed vertical axle 101 integrated into housing 100which enables the pinion gear 7 a to be inserted into the assembledcatheter anchoring device. The key in vertical axle 101 in turn preventsvertical movement of pinion gear 7 a after rotation caused by theassembly of racks 12 as shown in FIG. 4. Each button 6 is an integralmember of one end of rack 12 and perpendicular to the rack. Reference ismade to FIG. 5 which is an exploded diagram of the catheter anchoringdevice. Catheter locking pin 8 contains an integral leaf spring whichapplies downward force toward the bottom of housing 100 in its unsprungposition and prohibits the turning of pivoting wings 9 when the catheterchannel 2 is empty (i.e. no catheter is present) by mechanicallyinterfering with the rotation of pivoting wings 9. It should be notedthat caps 102 a and 102 b, in one embodiment, are slid into place ontohousing 100 and locked in place during the assembly process to becomeintegral members of housing 100.

When a catheter 1 (i.e. one which conveys fluids, gases, or electricalcurrent or any combination thereof) of correct diameter is placed incatheter channel 2 and the bottom surface of the catheter anchoringdevice is pressed against the surface of the skin of a patient by theoperator (as shown in FIG. 6), the catheter locking pin 8 will bedisplaced upward orthogonal to the bottom surface of housing 100,compressing its integral leaf spring and disengaging the locking channelin both pivoting wings 9 thus allowing the rotation of pivoting wings 9.The rotation of pivoting wings 9 allows the racks 12 to move inward intohousing 100 when buttons 6 are pressed inward parallel to the surface ofthe patient's skin. Pinion gear 7 a keeps the two racks 12 and twopivoting wings 9 in synchronization with one another.

The sharpened tips of both pairs of parallel radial sharps 4 remainlocked within housing 100 of the device until the buttons 6 are pressedtoward each other as shown in FIG. 2. Both pivoting wings 9 rotate abouta common axle 10 in opposite directions. A torsion spring 16 alsorotates about axle 10 and is captured between pivoting wings 9. The endsof torsion spring 16 are mechanically coupled to each pivoting wing 9 sothat equal and opposite force is applied to each pivoting wing 9 tocause rotation toward its fully open position which is limited by apreset mechanical interference between both pivoting wings 9. In thedisengaged position, torsion spring 16 is slightly tensioned. Thetorsion spring 16 is further tensioned by the rotation of the pivotingwings 9 away from their fully disengaged position. Each pivoting wing 9contains an integral pinion gear 9 b at the opposite end from itsrespective tang 9 a. Each integral pinion gear 9 b rotates perpendicularto the rotation of pinion gear 7 a and engages the integral teeth ofrack 12 on the top surface of the common rack 12. Each rack 12 also hasteeth on the perpendicular surface facing the center of the device whichengages pinion gear 7 a. No motion of the pivoting wings 9 can takeplace until catheter locking pin 8 has been displaced by a catheter 1placed within the catheter channel 2 and the catheter anchoring devicehas been pressed firmly against the surface of the patient's skin by theoperator. When the catheter locking pin 8 has been pushed upwardsagainst its integral leaf spring to its unlocked position, the buttons 6can be pressed inward toward each other. As buttons 6 are pressed towardeach other, racks 12 move parallel to the surface of the patient's skinwhile simultaneously engaging pivoting wings 9 via their respectiveintegral pinion gears 9 b. The parallel rack and pinion gear 7synchronizes the motion of the pivoting wings 9 so that each pivotingwing 9 moves with equal force and distance relative to the surface ofthe patient's skin. As buttons 6 move closer together, pivoting wings 9rotate around common axle 10, and pivoting wings 9 are rotated downtoward the top surface of the housing of the device. This in turn drivesthe sharpened ends of each pair of radial sharps 4 through theirrespective grooves 13 in the housing 100. As the sharpened end of eachradial sharp 4 protrudes below the bottom surface of housing 100 thoughits respective outlet hole 14 as shown in FIG. 2, the sharpened point ofeach radial sharp 4 pierces membrane 15 that covers the entire bottomsurface of housing 100 of the catheter anchoring device. Membrane 15 ismade of a soft and pliable material that will not irritate the skin suchas silicone. Membrane 15 may be nominally 0.5-1 mm thick. When eachradial sharp 4 penetrates the membrane 15, the membrane 15 will sealaround the outer diameter of the radial sharp 4. This in turn will keepbiological fluids and contaminants (blood, exudates, effluence, etc.)from entering the housing and potentially causing an infection to thepatient. As the radial sharps 4 are driven through the bottom surface ofmembrane 15, the pointed ends of sharps 4 pierce the surface of thepatient's skin and penetrate through the epidermis and dermis layersinto the subcutaneous layer of the patient's skin as shown in FIG. 7.

When buttons 6 have been engaged fully and are flush with housing 100 ofthe device, the two pairs of diametrically opposed radial sharps 4 willbe fully deployed underneath the patient's skin at a maximum depth ofapproximately 4-5 mm in the subcutaneous layer of the patient's skin.The oppositely sharpened tips of each pair of diametrically opposedradial sharps 4, having mating oppositely-formed angular tips, will nestwith each other at the nadir below the surface of the patient's skin,consequently forming a virtually solid arc as seen in FIG. 7. The twopairs of parallel diametrically opposed sharps 4 spaced by nearly thefull width of housing 100 as shown in FIG. 8 will form a solid andsecure anchor to the patient's skin. When buttons 6 have been fullyengaged, the integral pawl at the end of each locking arm 9 c will latchon the bottom surface of a release bar 18 located in its first detentposition in housing 100 as shown in FIG. 9, locking each pivoting wing 9into the fully deployed position until released by the operator. The topsurfaces of pivoting wings 9 will be flush with the top surface ofhousing 100 in the fully deployed position.

With the catheter anchoring device fully attached to the patient andlocked in position, the catheter 1 can be secured to the catheteranchoring device by means of catheter lock 19. In the unlocked position,catheter lock 19 is held in place by a pair of diametrically opposedintegral pawls in integrated handles 19 b located on either side ofcatheter lock 19. Each pawl engages a respective detent 103 on eachrespective side of housing 100. Catheter lock 19 rotates along an axisin housing 100 parallel to the catheter 1 and directly above catheterchannel 2. The concave surface of catheter clamp 19 a of catheter lock19 is coated with a thin layer of non-slip pliable material such assilicone. The inner concave face of catheter channel 2 that is oppositethe concave surface of catheter clamp 19 a may also be coated with athin layer of non-slip pliable material such as silicone to provideadditional frictional resistance to catheter 1 when catheter clamp 19 ais in its locked position. When handles 19 b on either side of catheterlock 19 are pushed down toward the patient by the operator (e.g. usingthe operator's thumb and forefinger), each pawl in each respectivehandle 19 b are released from its respective detent 103. As the operatorpushes down on handles 19 b, the catheter clamp 19 a will rotate towardthe catheter 1 in catheter channel 2, compressing the side of thecatheter 1 very slightly but not inhibiting the flow in catheter 1 andgripping the catheter 1 between the catheter clamp 19 a and the oppositeconcave inner sidewall of catheter channel 2. Catheter lock 19 will lockinto the sides of housing 100 via a detent 104 on either side of housing100 engaged by each respective pawl in handle 19 b when the top surfaceof handles 19 b are flush with the top surface of housing 100. Inaddition to locking the catheter lock 19 in place, the detents 104 andmating channels contained within housing 100 for handles 19 b prohibitover-travel of the catheter lock 19 which in turn prohibits the catheterclamp 19 a from inhibiting the flow in catheter 1. FIG. 10 shows theside view of the catheter anchoring device with catheter lock 19 lockedin place by handles 19 b having engaged detents 104 and catheter 1securely gripped between the concave inner sidewall of catheter channel2 and the deployed catheter clamp 19 a. The resistance provided by thetensioned concave and silicone-coated catheter clamp 19 a and theopposite inner concave sidewall of the catheter channel 2 (which mayalso be coated with silicone) on either side of the catheter 1 withincatheter channel 2 along the entire length of catheter channel 2 aresufficient to keep the catheter 1 securely clamped in place (i.e. nomovement of the catheter can take place once catheter lock 19 has beenrotated into its detent locked position).

Once the catheter 1 has been locked in place, it will remain secureduntil the catheter 1 and the catheter anchoring device are removed bythe operator. The catheter 1 can be axially repositioned, if necessary,without removing the catheter anchoring device from the patient's skin.In the event of such repositioning the operator can unlock catheter lock19 by pulling the two handles 19 b of catheter lock 19 away from theside of housing 100 slightly and orthogonal to the side of housing 100and in the opposite direction from each other. This action releases thepawls in handles 19 b from their respective locked detents 104, and theoperator can then rotate the two handles 19 b in a direction away fromthe surface of the patient's skin to release the tension on the catheterclamp 19 a and its grip on the catheter 1. This rotational motion willreposition the integral pawls in handles 19 b into detents 103 whichwill keep catheter clamp 19 a away from the catheter 1. With thecatheter 1 now free to move within the catheter channel 2, the operatorcan reposition the catheter 1 to its new position, and catheter lock 19can be re-locked via the methodology described above to re-secure thecatheter 1 in its new position. This process may be repeated as manytimes as needed by the operator.

During the time that the catheter anchoring device is attached to thepatient, the surface of the skin surrounding the insertion points of thesharps 4 may be cleaned with an appropriate disinfecting solution suchas Betadine. A saturated swab or pad of disinfectant may be wiped and/orsqueezed at the surface of the patient's skin adjacent to the sides ofthe housing 100. The disinfectant will wick under the bottom surface ofthe catheter anchoring device near the sharp insertion sites, keepingthem free of potential infections. This process can be repeated asneeded while the catheter anchoring device is attached to the patient'sskin.

The catheter anchoring device may be removed easily at any time after itis attached to the patient's skin by the operator. The process forremoval has been specifically designed to be easy but deliberate tooperate in order to obviate an accidental removal of the catheteranchoring device that could have deleterious repercussions for thepatient. A safety mechanism is employed which requires both of releasebars 18 to be actuated in order to disengage the locks that hold thecatheter anchoring device in place. Therefore, actuating only onerelease bar will not disengage the locking mechanism that keeps thesharps 4 in their deployed positions which in turn keeps the catheteranchoring device securely attached to the patient's skin.

To remove the catheter anchoring device from the patient's skin, theoperator grasps either one of two release bars 18 protruding from theopposite sides of housing 100 (the order of actuation isinconsequential) between his/her thumb and forefinger via its integralridged grip and pulls release bar 18 to its second detent position.Pulling the release bar 18 to its second detent position accomplishestwo mechanical functions simultaneously. First, the pawl at the end oflocking arm 9 c in the respective pivoting wing 9 will be unlatched fromthe underside of release bar 18 via a slot in the release bar 18 that isslid into position in the second detent position. Second, release bar 18is permanently locked into a detent in housing 100 via a pawl on theunderside of release bar 18 which is attached to release bar 18 by aflexible member as shown in FIG. 5. Consequently, release bar 18 cannotbe re-engaged once the operator has pulled release bar 18 into thesecond detent position, prohibiting the reuse of the intentionallydisposable catheter anchoring device. Once the first release bar 18 hasbeen locked into its second detent position, the operator repeats theprocedure with the second release bar 18 on the opposite side of housing100. Pulling the second release bar 18 into its second detent positionaccomplishes the same two mechanical functions as the first release bar18 as described above. Upon unlatching of the pawl at the end of lockingarm 9 c in the respective second pivoting wing 9, the tensioned torsionspring 16 instantly recoils to its relaxed and undeployed position,pulling both pivoting wings 9 to their original undeployed positions viatheir integral pinion gears 9 b acting on their respective racks 12. Aspivoting wings 9 spring back toward their undeployed positions, the twopairs of parallel sharps 4 are retracted from the patient's skin nearlyinstantly and the sharpened ends of sharps 4 are encapsulated completelywithin housing 100 within their respective grooves 13 as shown in thecross-sectional view in FIG. 11. Torsion spring 16 has sufficient forceto remove all four radial sharps 4 simultaneously from the patient'sskin virtually instantaneously. Torsion spring 16 also simultaneouslyforces racks 12 to their respective undeployed positions where a pawl ona flexible member at the internal end of each respective rack 12 latchesonto each respective release bar 18 in its second detent position,permanently locking racks 12, pivoting wings 9, and pinion gear 7 a ofmechanism 7 in the undeployed position thus preventing any re-engagementof the catheter anchoring device. Consequently, the sharpened ends ofradial sharps 4 which are now fully contained and locked within housing100 cannot be exposed to the operator or anyone else ever again,completely obviating any chance for an inadvertent needlestick injury.

In the unlikely event that the mechanism to automatically release thespring-loaded sharps 4 from the patient's skin fails to operate asintended, a backup failsafe mechanism can be manually manipulated by theoperator to release radial sharps 4 from the patient's skin. A smallopening 20 (as shown in FIG. 12) in each button 6 enables the operatorto insert a small tool such as a Kelly clamp or the head of a smallflat-bladed screwdriver into opening 20 to force the pivoting wing 9 todisengage. This will force the second pivoting wing 9 to disengage,allowing torsion spring 16 to return both pivoting wings 9 to theirundeployed positions. In this scenario, the operator should apply asmall amount of force to overcome the malfunctioning release bar 18.Even using this manual backup procedure, the operator is fully protectedfrom an inadvertent needlestick injury since the torsion spring 16 willstill perform as intended. Additionally, a hole in each release bar 18is provided as a backup mechanism as a means for pulling the release bar18 into the second detent position in the event that the operator cannotpull release bar 18 with his or her fingers (e.g. if the release bar 18becomes slippery due to liquid, blood, or effluence). The operator mayalso use a Kelly clamp or other small tool to grasp the release bar 18via the hole in its surface to pull release bar 18 into its seconddetent position.

The methodology described above for removal enables the operator todispose of the catheter anchoring device with the catheter 1 stillattached. Alternatively, the operator may unlock catheter lock 19 beforeengaging the release mechanism via release bars 18 as previouslydescribed. Using this methodology, the catheter anchoring device andcatheter 1 can be removed from the patient and disposed of separately.In either scenario, the protection against an inadvertent needlestickinjury to the operator or anyone else is exactly the same.

In the embodiment described above, housing 100 and all of the internalcomponents as seen in FIG. 5 with the exception of the parts noted abovethat are made of a pliable material and torsion spring 16 may beconstructed from any sterilizable, rigid material that is medically safeto be in contact with a patient's skin including but not limited toplastics and/or metals. Torsion spring 16 is intended (but not limited)to be constructed of a suitable metal such as stainless steel or springsteel with the proper spring properties. Radial sharps 4 and integratedcrossbar 4 a may be formed from a single piece of wire stock suitablefor insertion into the skin of a patient such as hardened surgicalstainless steel. Radial sharps 4 a can also be coated with a layer ofnickel or other suitable material which has properties that reduce therisk of infection. It is the intention of this embodiment that radialsharps 4 are rigid and very difficult to bend or deform. Membrane 15 andthe concave inner surfaces of catheter clamp 19 a and the sidewall ofcatheter channel 2 may be made of any material suitable for medical usethat is pliable and has frictional characteristics similar to siliconeand that will also not irritate the skin. In one embodiment of thecatheter anchoring device radial sharps 4 and their integrated crossbars4 a are made of hardened and tempered surgical stainless steel coatedwith a layer of nickel to reduce the risk of infection, and membrane 15and the concave inner surface of catheter clamp 19 a and the concaveinner surface of the sidewall of catheter channel 2 are made ofsilicone. In this one embodiment all other components of the catheteranchoring device except axle 10 and torsion spring 16 as described aboveare made from a rigid injection molded plastic. In this one embodimentaxle 10 is made from surgical stainless steel. One of ordinary skill inthe art will recognize that a variety of materials and combinationsthereof could be used to achieve the properties of the variouscomponents of the catheter anchoring device described.

The embodiment described above contains two pairs of diametricallyopposed radial sharps 4 that move coaxially. In another embodiment,there may be one pair of diametrically opposed radial sharps or three ormore pairs of radial sharps. The two pair of diametrically opposedradial sharps 4 described above are parallel along the same radius ofcurvature to each other. In another embodiment, the two pair ofdiametrically opposed radial sharps 4 may be rotated away from eachother by a small angle so that when viewed from either end of thecatheter anchoring device they form a slightly obtuse angle relative tothe center of housing 100 and do not rotate coaxially. This embodimentcan add further stability to the catheter anchoring mechanism especiallyin applications for large diameter catheters. In another embodiment,either or both of the concave inner surfaces of the catheter clamp 19 aand the inner sidewall of catheter channel 2 can be coated with a layerof silicone or other non-slip material. In another alternate embodimentcatheter lock 19 can utilize a sliding mechanism to move it from itsunlocked position into its locked position rather than the rotatingmechanism as described. In another embodiment catheter lock 19 canutilize a spring-loaded push on/push off mechanism. In anotherembodiment, channels may be incorporated into housing 100 thatfacilitate the delivery of disinfecting fluids to the sharp insertionsites and/or that facilitate the drainage of fluids and wound exudatesfrom the sharp insertion sites.

In another embodiment the buttons 6 when fully deployed may extendoutward slightly from housing 100 as shown in FIG. 12A rather than restflush with housing 100. The increased button depth prevents the user'sfingers from getting too close to the pivoting wings 9 and minimizingthe risk that a user's surgical glove will be inadvertently caught inthe pivoting wings 9 as they close and latch during deployment of thecatheter anchoring device.

In another embodiment the removal of the catheter anchoring device maybe accomplished by pushing both release bars 18 inward toward housing100 rather than pulling the release bars 18 away from housing 100. Thisis accomplished by orienting the exposed grips of each release bar 18through the opposite side of housing 100 from the side of housing 100 asdescribed in the embodiment above. In this embodiment the user pushesthe release bars 18 from their first detent positions toward the housingto their second detent positions. The resulting mechanical actuation asdescribed in the embodiment above is then exactly the same upon thesecond release bar 18 reaching its second detent position provided thatthe first release bar 18 is also in its second detent position. Similarto the embodiment as described above the order of actuation of eachrelease bar 18 is inconsequential. In another embodiment the releasebars 18 may be oriented so that one release bar must be pushed towardhousing 100 to move it from its first detent position to its seconddetent position while the second release bar 18 must be pulled away fromhousing 100 to move it from its first detent position to its seconddetent position. In this embodiment as well the order of actuation ofeach release bar to remove the catheter anchoring device isinconsequential.

In another embodiment each pair of radial sharps 4 are independentlyconnected to each pivoting wing 9 and no crossbar 4 a connects the pairof radial sharps 4 to that pivoting wing 9. In this embodiment themechanical operation of the radial sharps 4 attached to the pivotingwing 9 is the same as described in the first embodiment.

Furthermore, embodiments can to be used to anchor many types and sizesof catheters, drains, electrical catheters such as transvenous pacemakerwires, or nearly any type of other medical conduit that delivers fluids,medicines, or gases to the human body or extracts fluids or gases fromthe human body—any of such catheters or conduits which may be anchoredto a patient's skin while in service. The embodiment described aboveillustrates a typical example of a catheter anchoring device for aspecific catheter size (i.e. the diameter of the catheter). Theembodiment described above can be modified to accommodate any specificsize of catheter, drain, or medical conduit. For example, for nearly anysmall diameter catheter, drain, or conduit, the size of the catheterchannel 2, inner concave sidewall of the catheter channel 2, andcatheter lock mechanism 19 would be scaled appropriately to accommodatethe specific catheter diameter. In larger diameter catheter applicationssuch as chest tubes, for example, the entire size of the catheteranchoring device could be scaled and/or the catheter locking mechanism19 as described above made larger to appropriately accommodate the sizeof the catheter 1 and provide sufficient anchoring strength to securelyhold the catheter 1 in place.

In practice, an operator (typically a physician in the United States)will insert a catheter 1 into a patient using a known methodology. Oncethe catheter 1 has been inserted, the operator will remove the catheteranchoring device from its factory-sealed package. The catheter anchoringdevice is fully sterile when it is removed from its sealed packaging.Due to the mechanical interlock failsafe mechanism described above, thefour pointed ends of the radial sharps 4 are safely and securely encasedwithin housing 100 of the catheter anchoring device and cannot bedeployed accidentally in any way before the device is properlypositioned on the patient's skin. The operator cleans the surface of theskin with a disinfecting solution such as Betadine where the catheteranchoring device is to be placed. The operator may also apply a topicalanesthetic on the patient's skin. The operator then places the catheteranchoring device on the patient's disinfected skin near the insertionsite for the catheter 1. The catheter anchoring device is positionedover the catheter 1 which lies parallel to the surface of the skin sothat the catheter 1 lies lengthwise within catheter channel 2. With theoutlets for the radial sharps 4 safely pressed against the patient'sskin, the mechanical interlock failsafe mechanism is released by thepresence of the appropriately-sized catheter 1 within catheter channel 2which displaces catheter locking pin 8 as the operator presses thecatheter anchoring device toward the patient's skin. With one hand theoperator grasps the two buttons 6 between his/her thumb and forefinger;and while applying light pressure toward the surface of the patient'sskin, the operator squeezes buttons 6 inward deploying radial sharps 4.

The sharpened tips of radial sharps 4 penetrate the membrane 15 on thebottom surface of the catheter anchoring device through outlet holes 14and enter the surface of the patient's skin. As each radial sharp 4penetrates membrane 15, the pliable silicone material self-seals aroundthe outer diameter of each radial sharp 4, prohibiting blood, exudates,and other contaminants from being drawn into the separate grooves 13which guide each individual radial sharp 4. This self-sealing processreduces the risk of infection to the patient while the catheteranchoring device is attached to the patient's skin. As the actuationmechanism is engaged by the operator, the radial sharps 4 penetrate theepidermis, dermis, and subcutaneous layers of the skin. When buttons 6have been fully engaged by pressing them toward each other and thebuttons 6 are flush with housing 100, a positive detent caused by thelatching of the pawl on the end of each pivoting wing locking arm 9 conto its respective release bar 18 will be felt by the operator (and anaudible click will be heard by the operator as well) to let the operatorknow that the catheter anchoring device has been locked securely inplace. As the catheter anchoring device is locked into its fullydeployed position, the oppositely-sharpened ends of each pair ofdiametrically opposed radial sharps 4 nest into each other forming anearly solid arc at a preset depth of approximately 4-5 mm beneath thesurface of the patient's skin in the subcutaneous layer. This nesting ofeach pair of the sharpened ends of each pair of radial sharps 4eliminates the “splinter effect” for the patient. Penetration of theradial sharps 4 to the subcutaneous layer provides maximum holdingstrength for the catheter anchoring device while reducing potentialrisks to the patient as previously enumerated and reduces discomfort tothe patient while the catheter anchoring device is attached to thepatient's skin. When the catheter anchoring device has been secured tothe patient's skin, the operator then locks the catheter 1 in place tothe catheter anchoring device by pushing down lightly on the handles 19b of catheter lock 19 (e.g. using the operator's thumb and forefinger).When the pawls in each handle 19 b engage their respective detents 104in housing 100, the operator will feel and hear the positive engagementof catheter lock 19 to let him/her know that the catheter 1 is fullylocked. The operator may also visually confirm that the catheter 1 islocked in place by catheter lock 19 by noticing that the top surfaces ofhandles 19 b are flush with the top surface of housing 100. Aspreviously described, the engagement of catheter lock 19 very slightlycompresses the catheter 1 (without inhibiting its flow) between theconcave inner surface of catheter clamp 19 a and the inner concavesidewall of catheter channel 2 opposite it. Since one or both concavesurfaces are coated in silicone which has non-slip properties, thecatheter 1 is held securely once gripped within catheter channel 2 bycatheter lock 19.

After confirming the insertion depth of the catheter 1 by x-ray or othermeans or for any other reason, the operator may reposition the catheter1 after releasing catheter lock 19 using the procedure described above.Once the catheter 1 has been placed in its new position by the operator,the catheter 1 can be re-secured using the catheter locking proceduredescribed above. This process can be repeated as many times as necessaryby the operator without having to detach the catheter anchoring devicefrom the patient's skin. The unlocking mechanism has been designed to bevery deliberate in actuation so that the catheter lock 19 cannot beaccidentally disengaged by the patient or anyone else, for an accidentaldislodgement of the catheter 1 could have serious consequences for thepatient. As is standard practice with sutured catheters, the catheteranchoring device can also be covered in medical tape that is attached tothe patient's skin after the catheter anchoring device has been securedto the patient's skin if desired. While the catheter anchoring device isattached to the patient's skin, each pair of sharpened ends of theradial sharps 4 are securely nested into each other 4-5 mm below thesurface of the patient's skin directly underneath the body of thecatheter anchoring device. Consequently, radial sharps 4 which are nowcontaminated with the patient's blood are prevented from causing anaccidental needlestick injury to the operator, any other medicalpersonnel, or anyone else while the catheter anchoring device isattached to the patient's skin. Unlike sutured catheters and otherconventional catheter anchoring devices, the ends of the sharps 4 of theembodiments only penetrate the skin once and remain embedded in the skin(i.e. they are not exposed to the air and/or contaminants) until thecatheter anchoring device is removed from the patient's skin when sharps4 are withdrawn from the skin. This further reduces the previouslyenumerated risks of infection which can be very serious or even fatalfor the patient. While the catheter anchoring device is attached to thepatient's skin, the four small wound sites as well as the catheteranchoring device itself can be cleaned as often as needed using theprocedure described above to reduce the risk of infection.

When the operator wishes to remove the catheter 1 from the patient, theoperator may either detach the catheter 1 from the catheter anchoringdevice via unlocking catheter lock 19 or the operator may leave thecatheter anchoring device attached to the catheter 1 for disposal withthe catheter 1. Under the first scenario, the operator first disengagescatheter lock 19 via the procedure described above. In either scenario,the operator will grasp either of the two release bars 18 with his/herthumb and forefinger using its integral ridged grip and pull it slightlyaway from housing 100 to its second detent position. The operator willfeel release bar 18 lock into its second detent position, and releasebar 18 will be locked in place prohibiting over-travel or redeploymentof release bar 18. The operator then grasps the sides of the catheteranchoring device with one hand; and with the other hand, the operatorgrasps the second release bar 18 with his/her thumb and forefinger usingits integral ridged grip. When the operator pulls the second release bar18 away from housing 100 to its second detent position, the failsafemechanism will unlock. Immediately upon the unlocking of the failsafemechanism, the tensioned torsion spring 16 will instantly retract allfour radial sharps 4 from the patient's skin and safely secure theirsharpened ends completely within housing 100. Since the catheteranchoring device prevents removal from the patient's skin before all ofthe sharpened ends of radial sharps 4 have been safely locked withinhousing 100, the potential for needlestick injuries to the operator orany other personnel are reduced. Due to the mechanical failsafeinterlock that is engaged upon release of radial sharps 4 from thepatient's skin, the pointed ends of radial sharps 4 are locked withinhousing 100 of the catheter anchoring device and are prevented frombeing accidently redeployed. Therefore, no needlestick injury can occurto the operator, other medical personnel, or anyone else after thecatheter anchoring device has been removed from the patient's skin. Thecatheter anchoring device can then be disposed of safely and properlywith or without the catheter attached as described above.

As previously described, the process of attaching the catheter anchoringdevice can be accomplished in just a few seconds easily by the operator.If less than ideal conditions exist or if a patient is unable to or isunwilling to remain motionless during the insertion procedure, then theextremely quick installation procedure will permit the operator toattach the catheter anchor nearly instantly without risk of aneedlestick injury to the operator or injury to the patient. The processof unlocking and relocking the catheter 1 in catheter lock 19 in orderto reposition the catheter can also be accomplished in a matter of a fewseconds. Lastly, the removal process also takes only a few seconds bythe operator to achieve.

In another embodiment, a pair of helical sharps may secure the catheteranchoring device to the patient's skin in place of the two pairs ofradial sharps and their associated pivoting wings previously described.Both helical sharps are wound in the same hand, either both woundclockwise or both wound counter-clockwise. Each helical sharp is mountedto and allowed to slide in a vertical groove in a drum with an integralpinion gear that is coaxial with its respective helical sharp, and itsaxis of rotation is orthogonal to the patient's skin. The helical sharpsare guided by helical grooves in the housing. The pitch of each helicalsharp is different thus allowing the drums and their sharps to bemounted next to each other. When the pinion gear on the drum is turnedby its respective rack, the drum turns the helical sharp in thedirection of its winding. This rotates the sharp about its axis; andguided by the grooves in the housing, the sharp is driven downwardtoward the patient's skin. The pointed end of each helical sharp issharpened to easily penetrate the patient's skin. At full deployment,the pointed end of each sharp penetrates to the subcutaneous layer ofthe patient's skin. The windings of the pair of helical sharps aredesigned so that at full deployment their respective tips come to resttouching each other.

In this embodiment of the catheter anchoring device, a mechanicalfailsafe mechanism similar to the first embodiment is employed. Due tothe fully deployed geometry of the helical sharps, the catheter channelis positioned next to the pair of helical sharps (i.e. off-center) inthe housing. In the undeployed position, the sharpened tips of thehelical sharps are fully encased within the housing, and the failsafemechanism prevents the deployment of the sharps until a properdeployment condition has been achieved. A catheter locking pin preventsthe movement of the rack and pinion gears until a catheter of propersize is located within the catheter channel and the housing is pressedagainst a patient's skin. When the catheter locking pin releases therack, the operator can push the buttons toward the centerline of thedevice parallel to the surface of the patient's skin which compresses aspring element. The movement of each rack rotates each drum which turnsthe sharpened end of each helical sharp downward through its respectivehelical groove in the housing and out through its respective outlet inthe housing. The bottom of the housing is completely covered with alayer of silicone similar to the first embodiment. As the buttons arepressed inward, the sharpened ends of the helical sharps pierce themembrane and then penetrate the surface of the patient's skin. When thebuttons are fully compressed (i.e. they are flush with the housing), thesharps reach their maximum depth of penetration into the patient's skinand the tips of each sharp come to rest touching point to point in thesubcutaneous layer of the patient's skin. A pawl at the end of each racklatches onto its respective release bar in its first detent position tolock the catheter anchoring device securely on the patient's skin in amanner similar to the first embodiment. Similar to the first embodimentpreviously described, the catheter can be released, repositioned, andre-secured as needed via a catheter locking mechanism as previouslydescribed. When the operator wishes to remove the catheter anchoringdevice, the operator pulls both release bars in a similar manner to thefirst embodiment to their second detent positions. Upon release of thesecond release bar by moving it into its second detent position, thepinion gears driving the helical sharps will be freed to rotate. Thecompressed spring element will instantly relax to its unsprung positionwhich will rotate the drums, retracting the helical sharps from the skinand completely encasing them within the housing. The pawls at the endsof the racks will latch onto the release bars in their locked seconddetent positions, prohibiting the catheter anchoring device and itshelical sharps from being redeployed. The catheter anchoring device canthen be safely disposed of by the operator. This embodiment protects theoperator, the patient, and any other personnel from an inadvertentneedlestick injury in the same manner as the first embodiment.

In another embodiment of the catheter anchoring device, the catheterlocking mechanism is an integral part of the failsafe interlockmechanism. In this embodiment, the rotating catheter locking mechanismdescribed in the first embodiment is replaced by a linear push on/pushoff slide mechanism incorporated into one of the two buttons. A firstbutton operates a pinion gear through two integral parallel racks sothat pushing this button inward actuates both pivoting wings and theirrespective radial sharps simultaneously. Similar to the first embodimenta mechanical failsafe mechanism prevents the deployment of the sharpsuntil the catheter anchoring device has been placed over a catheter ofproper size on the patient's skin and pressure has been placed on thedevice toward the patient's skin. When this condition has been achieved,the catheter locking pin disengages the respective channels in thepivoting wings, releasing the rack and pinion gear mechanism andenabling the operator to deploy the sharps by grasping the devicebetween the operator's thumb and forefinger and pressing the firstbutton inward toward the centerline of the device. The second button onthe device remains locked in place until the first button has been fullydepressed, the radial sharps have been fully deployed, and the pawls atthe ends of the locking arms of the pivoting wings have latched ontotheir respective release bars.

Once the catheter anchoring device is attached to the patient's skin andin its locked fully-deployed position, the interlock for the secondbutton is disengaged allowing the second button to operate. Pushing thespring-loaded second button to its second detent position slides theconcave end of the catheter clamp against the catheter and grips thecatheter between the catheter clamp and the concave sidewall of thecatheter chamber in a manner similar to the first embodiment. Pushingthe button inward slightly releases the button from its second detentposition, and the compressed spring returns the button to its firstundeployed position. This in turn releases the catheter from thecatheter clamp so that it can be repositioned and then subsequentlyre-secured by the operator. The operator may repeat this procedure asmany times as needed.

The operator may remove the catheter anchoring device from the patient'sskin in a manner similar to that of the first embodiment described aboveby pulling both release bars into their second detent positions. Uponrelease of the second release bar, the radial sharps automatically andnearly instantly fully retract from the patient's skin, and the pointedends of the radial sharps are locked permanently and safely within thehousing of the catheter anchoring device so that no needlestick injurycan occur.

In another embodiment of the catheter anchoring device two pairs oflinearly opposed sharps are employed to secure the catheter anchoringdevice to the patient's skin. In this embodiment, a housing section 200is connected to a housing section 210 by an integral feature in housingsection 210 which mates with a channel 201 (not shown) in housingsection 200 in a first detent position shown in FIG. 13. A coiled spring30 is connected on one end to housing section 200 and on the other endto housing section 210, and in its relaxed position, coil spring 30keeps housing section 200 and housing section 210 a preset distanceapart. Housing section 200 and housing section 210 have flat bottomsurfaces that are co-planar, and each bottom surface (202 and 211respectively) is covered with a layer of non-slip pliable material suchas silicone.

To fasten the catheter anchoring device in this embodiment to thepatient's skin, the operator places the flat bottom side of the deviceon the patient's skin with the longitudinal axis of the deviceperpendicular to the catheter 100 that has already been inserted intothe patient. Using the operator's thumb and forefinger, the operatorgrips both buttons 32 and 33 on opposite ends of the device. Using lightdownward pressure to press the silicone covered bottom of the catheteranchoring device onto the patient's skin, the operator squeezes the twohousing sections 200 and 210 toward each other. The non-slip surface ofthe silicone will grip the surface of the skin by friction. As the twosections of the housing are pushed toward each other, the skin isgathered between the two housing sections and will be forced upward andfill skin cavity 34 formed between the housing sections. Skin cavity 34is designed so that the maximum height of the skin gathered isapproximately 5 mm. When housing sections 200 and 210 have reached apreset minimum distance between them as shown in FIG. 14 and thepatient's gathered skin has filled skin cavity 34, a skin locking pin 35(similar to the catheter locking pin in the first embodiment) will bepushed upward against its integral spring by the gathered skin therebyreleasing the failsafe interlock mechanism. The release of the failsafeinterlock mechanism will then enable a pawl in the integral member ofhousing 210 to latch onto a detent in housing section 200 which willlock the two housing sections together permanently.

If the operator has failed to gather a sufficient amount of thepatient's skin in skin cavity 34, then skin locking pin 35 will preventthe failsafe mechanism from releasing and the two sections of thehousing from locking together. In this event the operator may relax thegrip on the buttons 32 and 33, and the compressed coiled spring 30 willreturn the catheter anchoring device to its original undeployed positionso that the operator can reattempt to properly deploy the device.

When the skin interlock has been satisfied by the presence of thegathered skin in skin cavity 34 and skin locking pin 35 has beenreleased, buttons 32 and 33 are mechanically freed to move fartherinward. Each button acts on a pair of parallel linear sharps 36 that arecompletely encased within their respective housing section untildeployed. The parallel linear sharps 36 can be joined on their non-sharpends by a crossbar 36 a (not shown) that is perpendicular to bothsharps. In one embodiment of the catheter anchoring device, each pair oflinear sharps 36 and its respective integral crossbar 36 a are formedfrom one continuous piece of surgical stainless steel wire stock. Thepointed ends of the sharps 36 are sharpened to easily penetrate theskin, and each pair is sharpened with mating congruent angles fornesting with the opposing pair of sharps 36. Each button acts on eachpair of linear sharps 36 through an integral feature that isperpendicular to the surface of the button. Each button also compressesa coiled spring 37 (not shown) as it is pressed toward the center of thecatheter anchoring device. When pushed by its respective button, eachpair of linear sharps 36 slides toward skin cavity 34 through a channelin its respective housing section. The sidewalls of skin cavity 34 arecoated with a thin membrane of silicone so that when the pointed ends ofeach pair of parallel linear sharps 36 penetrate the sidewall of skincavity 34 through their respective outlet holes, the membrane will sealaround the outer diameter of each linear sharp 36, keeping blood,effluence, and wound exudate from entering the housing.

As the operator squeezes buttons 32 and 33 toward each other, the twopairs of linear sharps 36 pierce the membrane of the sidewalls of skincavity 34 and penetrate the gathered skin of the patient in skin cavity34. When buttons 32 and 33 are fully depressed and flush with theirrespective sides of the housing, each pair of sharps 36 will protrudefrom the sidewall of the housing by half the width of skin cavity 34parallel to the bottom surface of the housing as shown in FIG. 15. Thesharpened points of each opposed pair of sharps 36 will nest with eachother due to their mating congruent angles in the subcutaneous layer ofthe patient's skin gathered in skin cavity 34, forming a nearlycontinuous linear anchor that will secure the catheter anchoring deviceto the patient's skin as shown in FIG. 16 and reduce the splinter effectwhile the catheter anchoring device is attached to the patient's skin.When the buttons are fully deployed, a pawl at the end of each integralfeature of buttons 32 and 33 latches onto release bar 38 (not shown) tolock the buttons and the two pairs of parallel linear sharps 36 inplace.

The operator then places catheter 100 in the curved catheter holder 39as shown in FIG. 17. Catheter holder 39 has tabs emanating from itssides that hold the catheter 100 within its groove. The concave groovesurface of catheter holder 39 is coated with a layer of non-slipmaterial such as silicone.

The operator then slides cover 40 toward the center of the catheteranchoring device so that it mates with cover 41 as shown in FIG. 18.Cover 40 has features on the underside of its leading edge which willgently press and hold the catheter 100 into the groove of catheterholder 39 when cover 40 is closed but not impede the flow in thecatheter 100. This coupled with the non-slip surface of catheter holder39 keeps the catheter 100 secured so that it cannot move while cover 40is closed. A pair of integral pawls in cover 40 lock into a mating pairof detents in housing section 210 to keep cover 40 locked in place.

The operator may reposition the catheter 100 at any time, if necessary,without removing the catheter anchoring device from the patient's skin.The operator can unlock cover 40 when it is in its closed position byusing a sliding motion to move cover 40 to its open position, therebyreleasing its integrated pawls from their mating detents in housingsection 210. The catheter 100 can then be repositioned by the operatorsince the catheter 100 is free to move within catheter holder 39 whilecover 40 is open. The catheter 100 can be re-secured by closing cover 40and locking it into its closed detent position. This procedure can berepeated as often as necessary.

When the operator wishes to remove the catheter anchoring device fromthe patient's skin, the operator slides cover 41 away from cover 40,overcoming its two integral pawls and their mating pair of detents inhousing section 200 that hold cover 41 in its first detent position.This movement as shown in FIG. 19 exposes release button 38 a at one endof release bar 38. The operator then pushes release button 38 a whichmoves release bar 38 into its second detent position which accomplishestwo mechanical actions simultaneously. First, the pawls at the ends ofthe integral members of buttons 32 and 33 will be unlatched from releasebar 38, and the compressed coil springs 37 acting on each buttonassembly will return buttons 32 and 33 to their uncompressed statenearly instantly. This will automatically and nearly instantaneouslywithdraw the opposing sets of parallel linear sharps 36 from thepatient's skin and completely encase the two pairs of parallel linearsharps 36 within their respective sides of the housing. Second, releasebar 38 will be permanently locked into its second detent position inhousing section 200 via a pawl. In order to prohibit the reuse of thecatheter anchoring device, pawls on the integral members of buttons 32and 33 will engage release bar 38, and in turn, this will permanentlylock the two pairs of parallel linear sharps 36 safely and completelywithin their respective sides of the housing. The operator can thensafely remove the locked and secured catheter anchoring device from thepatient's skin without the risk of a needlestick injury to anyone andsafely dispose of the catheter anchoring device. FIG. 20 shows thecatheter anchoring device in its fully extracted position with thecatheter 100 still secured between catheter holder 39 and cover 40.Alternatively, the catheter 100 can be removed prior to extraction ofthe catheter anchoring device by sliding cover 40 to its open positionand removing the catheter 100 from catheter holder 39.

In the embodiment described above two pairs of parallel linear sharpsare specified. Alternatively, this embodiment may contain one set ofopposing linear sharps or three or more sets of opposing parallel linearsharps.

In all of the embodiments described, the sharps cannot be deployedbefore the catheter anchoring device has been placed safely onto thepatient's skin and an additional failsafe condition has been satisfied.The catheter anchoring device has to be properly located on thepatient's skin and in the case of all but the last embodiment, acatheter of appropriate size has to be within the catheter channelbefore the catheter locking pin will release the failsafe mechanism. Inthe last embodiment a similar failsafe mechanism requires that asufficient amount of the patient's gathered skin must be in the skincavity before the skin locking pin will release the failsafe mechanism.It is only under this condition that the sharps can be deployed, andconsequently, the pointed ends of the sharps can be exposed only to thepatient's skin. Therefore, neither the operator nor anyone else can beexposed to the pointed ends of the sharps, obviating any risk of aninadvertent needlestick injury. While the catheter anchoring device isattached to the patient's skin, there is no risk of an inadvertentneedlestick injury to the operator or anyone else because the points ofthe sharps are safely below the housing within the subcutaneous layer ofthe patient's skin. And since the pointed ends of the sharps are fullyretracted from the patient's skin and fully encased and permanentlylocked within the housing before the catheter anchoring device can beremoved from the patient's skin, there is no risk to the operator oranyone else of an inadvertent needlestick injury after the catheteranchoring device has been removed from the patient's skin.

It should be noted that all of the embodiments described use similartechniques as the first embodiment to reduce the risk of infection tothe patient. Each of the embodiments may use materials similar to thefirst embodiment as described. Someone of ordinary skill in the art willrecognize that there are many variations and combinations of theembodiments described that can yield the desired attributes of thespecific catheter anchoring device embodiments described herein, and thespecific embodiments described herein are intended to be illustrativebut are not meant to limit the scope of the invention.

It should be noted that conventional catheter anchoring devices forpreventing needlestick injuries can easily have their sharpsaccidentally engaged prior to insertion and/or after their removalprocesses have been performed because they do not contain failsafeinterlock mechanisms to such actions. Consequently, operators who usesome conventional catheter anchoring devices could be vulnerable toinadvertent needlestick injuries and their resultant risks. Furthermore,there is nothing to prevent these conventional catheter anchoringdevices from being redeployed after removal from a patient's skin whichcould not only result in an accidental needlestick injury but could alsoresult in contaminating the patient with a serious infection. Unlikeconventional catheter anchoring devices, the chance of a needlestickinjury during the insertion or removal process or anytime the catheteranchoring device is not attached to the patient (either prior toinsertion or after removal) is reduced since the mechanical interlockmechanism locks the pointed ends of the sharps safely and completelywithin the housing and prohibits the pointed ends of the sharps frombeing exposed in any way to anyone. The failsafe mechanical interlockonly enables deployment of the sharps if the catheter anchoring deviceis on the surface of a patient's skin (where the ends of the sharps canonly be exposed to the patient) and a catheter of proper diameter ispresent in the catheter channel as would be the case in a properapplication of the catheter anchoring device. Furthermore, the only timethat the pointed ends of the sharps can be exposed is when they arebeneath the surface of the patient's skin, and consequently, they do notpose a risk of a needlestick injury to the operator or anyone else. Thepointed ends of the sharps are retracted (which occurs instantly byspring action) in order to remove the catheter anchoring device from thepatient's skin, thus reducing the risk of a needlestick injury to theoperator or anyone else.

It should be noted that while the foregoing has been described for usewith human patients, embodiments of the catheter anchoring device may beused for veterinary patients in a similar fashion.

The preceding description of the invention has been described withreference to various specific embodiments for the purposes ofillustration and description, but it is not intended to be exhaustive orto limit the invention to the precise form disclosed. Numerousmodifications and variations are possible within the scope and spirit ofthe inventive concepts described.

Having thus described at least one illustrative embodiment of theinvention, various alterations, modifications, and improvements willreadily occur to those skilled in the art. Such alterations,modifications, and improvements are intended to be within the spirit andscope of the invention. Accordingly, the foregoing description is by wayof example only and is not intended as limiting. The invention islimited only as defined in the following claims and the equivalentsthereto.

What is claimed is:
 1. An anchor device, the device comprising: ahousing having a bottom surface; at least one pair of sharps within thehousing, each sharp in the at least one pair of sharps having an endconfigured to pierce a skin surface; and a locking mechanism configuredto maintain the end of each sharp within the housing when the lockingmechanism is engaged and to enable each sharp to protrude from thebottom surface and to pierce a skin surface when the locking mechanismis disengaged. 2.-50. (canceled)